Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

JAA 1981-07-28

CARDIAC 1000 TM

Applicant American Edwards Laboratories

K-Number K811094

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FMF 1981-07-28

MONOJECT STERILE M506 6CC SYRINGES

Applicant Sherwood Medical Co.

K-Number K812023

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JTL 1981-07-28

STAPHASE*

Applicant Analytical Products, Inc.

K-Number K811982

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IFP 1981-07-28

10% NEUTRAL BUFFERED FORMALDEHYDE

Applicant Richard-Allan Medical Ind., Inc.

K-Number K811795

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FME 1981-07-28

MONITOR/VITAL SIGNS TRAY

Applicant American Hospital Supply Corp.

K-Number K811915

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DTN 1981-07-28

CARDIOTOMY RESERVOIR W/FILTER#BCR-3500

Applicant Bentley Laboratories, Inc.

K-Number K812009

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ESD 1981-07-28

EAGLE I HEARING AID

Applicant Electone, Inc.

K-Number K811988

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BZT 1981-07-28

LIFESOUND ESOPHAGEAL STETHOSCOPE

Applicant Biomedical Concepts, Inc.

K-Number K811928

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JES 1981-07-28

SE WON(ALUMINUM) DENTAL FLOSS HOLDER

Applicant Sewon Industry

K-Number K811926

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EBZ 1981-07-28

KULZER TRANSLUX VISIBLE LIGHT CURING

Applicant Kulzer, Inc.

K-Number K811668

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KBC 1981-07-27

SKIN STAPLE EXTRACTOR

Applicant Sierra Laboratories, Inc.

K-Number K811887

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N/A 1981-07-27

COMMAND P5(UNIPOLAR PULSE GENERATOR)

Applicant Cardiac Pacemakers, Inc.

K-Number K811401

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